CN109939141A - A kind of ketelin capsule and preparation method thereof - Google Patents
A kind of ketelin capsule and preparation method thereof Download PDFInfo
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- CN109939141A CN109939141A CN201910161799.5A CN201910161799A CN109939141A CN 109939141 A CN109939141 A CN 109939141A CN 201910161799 A CN201910161799 A CN 201910161799A CN 109939141 A CN109939141 A CN 109939141A
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- 239000002775 capsule Substances 0.000 title claims abstract description 150
- 238000002360 preparation method Methods 0.000 title claims abstract description 30
- 239000000843 powder Substances 0.000 claims abstract description 124
- 240000003537 Ficus benghalensis Species 0.000 claims abstract description 93
- 239000011812 mixed powder Substances 0.000 claims abstract description 70
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 claims abstract description 58
- 239000000654 additive Substances 0.000 claims abstract description 35
- 230000000996 additive effect Effects 0.000 claims abstract description 35
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 32
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 18
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 16
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 15
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 15
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims description 23
- 238000002156 mixing Methods 0.000 claims description 20
- 240000000231 Ficus thonningii Species 0.000 claims description 18
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- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 14
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 14
- 239000003607 modifier Substances 0.000 claims description 14
- 239000011975 tartaric acid Substances 0.000 claims description 14
- 235000002906 tartaric acid Nutrition 0.000 claims description 14
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- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 13
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- 229910002027 silica gel Inorganic materials 0.000 claims description 8
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- 238000000034 method Methods 0.000 claims description 4
- KAESVJOAVNADME-UHFFFAOYSA-N Pyrrole Chemical compound C=1C=CNC=1 KAESVJOAVNADME-UHFFFAOYSA-N 0.000 claims 2
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims 1
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- 238000002386 leaching Methods 0.000 claims 1
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- 239000011976 maleic acid Substances 0.000 claims 1
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- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 description 2
- 241000700199 Cavia porcellus Species 0.000 description 2
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- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
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- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 2
- 230000003419 expectorant effect Effects 0.000 description 2
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- 206010067484 Adverse reaction Diseases 0.000 description 1
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 1
- 241000700198 Cavia Species 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 241000544061 Cuculus canorus Species 0.000 description 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 1
- 241001465251 Ephedra sinica Species 0.000 description 1
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- 238000012449 Kunming mouse Methods 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- MKYBYDHXWVHEJW-UHFFFAOYSA-N N-[1-oxo-1-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propan-2-yl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(C(C)NC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 MKYBYDHXWVHEJW-UHFFFAOYSA-N 0.000 description 1
- NIPNSKYNPDTRPC-UHFFFAOYSA-N N-[2-oxo-2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 NIPNSKYNPDTRPC-UHFFFAOYSA-N 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 235000004347 Perilla Nutrition 0.000 description 1
- 244000124853 Perilla frutescens Species 0.000 description 1
- 201000005702 Pertussis Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
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- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to pharmaceutical technology fields, and in particular to a kind of ketelin capsule and preparation method thereof.Ketelin capsule provided by the invention, it is made of ketelin capsule mixed powder and capsule shells, the ketelin capsule mixed powder includes following components and its parts by weight: 350-370 parts of Foliole banyan dry extract powder, 1.2-1.5 parts of chlorphenamine maleate, 10-17 parts of talcum powder, 5-7 parts of magnesium stearate, 2-4 parts of polyvinylpyrrolidone, 1-2 parts of multifunction additive.Ketelin capsule provided by the invention has the advantages that stability is high, hygroscopicity is low, bioavilability is high, easy disintegrating, and in preparation process ketelin capsule mixed powder obtained mobility is high, uniform quality, solve the problems, such as quality difference in capsule filling.In addition, the uniformity of chlorphenamine maleate is high in ketelin capsule provided by the invention.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of ketelin capsule and preparation method thereof.
Background technique
Cough is common sympton, and morbidity has two kinds of reasons of exogenous disease and internal injury, the heresy of affection of exogenous wind-cold, from mouth and nose fur
Enter, impairment of purifying and descending function of the lung；Insufficiency of the spleen resulting in production of dampness, wet to be polymerized to phlegm, phlegm stagnation, lung qi does not drop；Liver depression forming fire, fiery Sheng Zhuo lung, impairment of purifying and descending function of the lung；Kidney
Gas virtual loss, failure of the kidney in receiving air etc. can lead to cough.Acute and chronic bronchitis in modern medicine, the infection of the upper respiratory tract, flu
Cough etc. belongs to this disease scope.Cough is clinical common frdquently encountered disease.
Current clinically used antitussive is the compound preparation of chemicals and Chinese medicine mostly.Chemicals presses town
The cough mechanism of action can be divided into two class of central and peripheral antitussive drugs.Central antitussive, be mostly opiates and its
Derivative, such as codeine (methylmorphine).This kind of drug discovery is early, antibechic effect is also preferable, but has dependence, therefore at present
Clinically using less.Peripheral antitussive drugs, such as coscopin, majority be also alkaloids medicament, can be generated when taking nausea,
The adverse reactions such as palpitaition, dizziness.And some Chinese medicines, such as fritillaria, Chinese ephedra, Radix Glycyrrhizae, purple perilla, cuckoo, the bark of ash, it has been proved have
Antitussive effect, these Chinese medicine majorities are to be applied to clinic in the form of compound preparation, but the treatment of the compound preparation of Chinese medicine is coughed
Effect is limited.
Chinese patent application CN102342977A discloses a kind of ketelin capsule and preparation method thereof, by Ficus microcarpa, horse
Carry out sour chlorphenamine composition.In the invention, the ketelin capsule is mainly used for treating chronic bronchitis.For anxious slow
Property bronchitis, bronchial asthma, cold cough, pertussis and various cough illness antibechics, eliminating the phlegm are relievingd asthma, anti-inflammatory.For cough
Asthma and chronic bronchitis cough.But chlorphenamine maleate fine powder is directly added into the preparation of the ketelin capsule thick
In cream, the uniformity of chlorphenamine maleate fine powder is bad.
Currently, that there are stability is undesirable for the capsule of existing treatment cough in the market, hygroscopicity and mobility need
Further increase, and in capsule chlorphenamine maleate fine powder the undesirable problem of uniformity.
Summary of the invention
In view of the deficiencies of the prior art, the purpose of the present invention is to provide a kind of ketelin capsules and preparation method thereof.
Ketelin capsule provided by the invention have stability is high, hygroscopicity is low, bioavilability is high, easy disintegrating it is excellent
Point, and in preparation process ketelin capsule mixed powder obtained mobility is high, uniform quality, solve quality in capsule filling
The problem of difference.In addition, the uniformity of chlorphenamine maleate is high in ketelin capsule provided by the invention.
The technical scheme is that
A kind of ketelin capsule is made of ketelin capsule mixed powder and capsule shells, the ketelin capsule mixed powder packet
Include following components and its parts by weight:
350-370 parts of Foliole banyan dry extract powder, 1.2-1.5 parts of chlorphenamine maleate, 10-17 parts of talcum powder, stearic acid
5-7 parts of magnesium, 2-4 parts of polyvinylpyrrolidone, 1-2 parts of multifunction additive.
Further, the ketelin capsule is made of ketelin capsule mixed powder and capsule shells, the ketelin capsule
Mixed powder is made of following components and its parts by weight:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, polyethylene
3 parts of pyrrolidones, 1.5 parts of multifunction additive.
Further, the average molecular weight of the polyvinylpyrrolidone is 8000-24000.
Further, the average molecular weight of the polyvinylpyrrolidone is 10000.
Further, the multifunction additive is by carboxymethyl chitosan, tartaric acid and microcrystalline cellulose by weight 2-
4:9-12:20-25 composition.
Further, the multifunction additive by carboxymethyl chitosan, tartaric acid and microcrystalline cellulose by weight
3:10:23 composition.
Further, the Foliole banyan dry extract powder is the modifier of Foliole banyan dry extract powder.
Further, the modifier of the Foliole banyan dry extract powder the preparation method comprises the following steps: take Foliole banyan dry extract powder, add
Enter superfine silica gel powder, the weight of superfine silica gel powder is the 1/95 of above-mentioned Foliole banyan dry extract powder weight, first with the speed of 300-500r/min
Degree stirring 10-15min, then with the speed of 1200-1500r/min stirring 6-10min to get.
The Foliole banyan dry extract powder the preparation method comprises the following steps: take Ficus microcarpa dried leaf, add water to cook twice, the additive amount of water
It is 4-6 times of above-mentioned Ficus microcarpa dried leaf weight, decocts 1.5h, second of decoction 1h, collecting decoction, 120 meshes for the first time
Filtration, filtrate are concentrated into the clear cream that relative density is 1.10-1.20 (80 DEG C), let cool, and ethyl alcohol is added and makes alcohol content up to 60%,
12-24h, filtration are stood, filtrate recycling ethanol is concentrated into the thick paste that relative density is 1.30 (50 DEG C), by above-mentioned thick paste and jade
Rice starch is dry at 60-75 DEG C after mixing evenly, and the amount of cornstarch is the 30%-35% of thick paste quality, be dried to moisture≤
When 5%, by the dry extract dried be broken into fine powder to get.
In addition, steps are as follows the present invention also provides the preparation method of ketelin capsule:
S1 takes the chlorphenamine maleate of formula ratio and Foliole banyan dry extract powder to be put into bag film inner sealing sack, Ficus microcarpa
The weight of dry extract is identical as the weight of above-mentioned chlorphenamine maleate, and shaking mixes, and 40 meshes excessively are primary, obtains mixed powder A；
S2 stirs evenly mixed powder A obtained by step S1 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
2 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder B；
S3 stirs evenly mixed powder B obtained by step S2 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
4 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder C；
S4 stirs evenly mixed powder C obtained by step S3 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
8 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain chlorphenamine maleate premixed powder；
S5 is by horse obtained by the Foliole banyan dry extract powder of surplus, talcum powder, magnesium stearate, multifunction additive and step S4
Carry out sour chlorphenamine premixed powder and is added to the mixer mixing, mixing speed 2000-3000r/min, mixing time 8-
15min obtains ketelin capsule mixed powder；
Ketelin capsule mixed powder obtained by step S5 is packed into capsule shells by S6, sterilizing to get.
In the present invention, by the way that Foliole banyan dry extract powder is carried out surface coating modification processing, Ficus microcarpa can not only be increased
The mobility of dry extract simultaneously reduces hygroscopicity, additionally it is possible to improve its uniformity.
In the present invention, multi-functional added by carboxymethyl chitosan, tartaric acid and microcrystalline cellulose by what certain weight ratio formed
Add agent that can not only enhance the stability of drug, further increases mobility, the uniformity of powder processing, make Ketelin obtained
Capsule mixed powder uniform quality solves the problems, such as quality difference in capsule filling, can also promote medicine disintegration, improves product
Quality.
Compared with prior art, present invention has the advantage that
(1) ketelin capsule provided by the invention has the function of antibechic, eliminating the phlegm, relievings asthma, anti-inflammatory, for treat cough and asthma and
Chronic bronchitis cough, it is curative for effect.
(2) ketelin capsule provided by the invention does not need adhesive and pressure in the preparation, but directly fills fine powder
Enter in capsule, dispersion is fast in the gastrointestinal tract, it is fast to absorb, and has the characteristics that bioavilability is high.
(3) for ketelin capsule provided by the invention convenient for taking, carrying, the compliance that user takes is good.
(4) uniformity of chlorphenamine maleate is high in ketelin capsule provided by the invention.
(5) ketelin capsule provided by the invention has the advantages that stability is high, hygroscopicity is low, easy disintegrating, and prepares
The mobility of ketelin capsule mixed powder obtained is high in journey, uniform quality, solves the problems, such as quality difference in capsule filling.
Specific embodiment
The following describes the present invention further through the description of specific embodiments, but it is to limit of the invention that this, which is not,
System, those skilled in the art's basic thought according to the present invention can make various modifications or improvements, but without departing from this
The basic thought of invention, is all within the scope of the present invention.
In the present invention, cornstarch is purchased from Xi'an Tian Zheng pharmaceutic adjuvant Co., Ltd, model: cp2015；Talcum powder can
Purchased from Wuhan Xin Yongqing Chemical Co., Ltd., pharmaceutical grade；Microcrystalline cellulose is purchased from Xi'an Wan Chang Biotechnology Co., Ltd, doctor
Medicine grade；Superfine silica gel powder is purchased from Xi'an Yue Lai Pharmaceutical Technology Co., Ltd, model: Meteorological Act；Carboxymethyl chitosan is commercially available westerly
The source An Tianguang Biotechnology Co., Ltd, model: TGY-002.
Ketelin capsule described in embodiment 1, a kind of ketelin capsule is made of ketelin capsule mixed powder and capsule shells, institute
Stating ketelin capsule mixed powder includes following components and its parts by weight:
350 parts of Foliole banyan dry extract powder, 1.2 parts of chlorphenamine maleate, 10 parts of talcum powder, 5 parts of magnesium stearate, average mark
Son amount is 2 parts of polyvinylpyrrolidone, 1 part of multifunction additive of 8000；The multifunction additive by carboxymethyl chitosan,
Tartaric acid and microcrystalline cellulose are formed by weight 2:12:25；The Foliole banyan dry extract powder is changing for Foliole banyan dry extract powder
Property object.
The modifier of the Foliole banyan dry extract powder the preparation method comprises the following steps: take Ficus microcarpa dried leaf, add water to cook twice, water
Additive amount be 4 times of above-mentioned Ficus microcarpa dried leaf weight, decoct 1.5h for the first time, decoct 1h for second, collecting decoction,
The filtration of 120 meshes, filtrate are concentrated into the clear cream that relative density is 1.10 (80 DEG C), let cool, and ethyl alcohol is added and reaches alcohol content
60%, stand 12h, filtration, filtrate recycling ethanol, be concentrated into relative density be 1.30 (50 DEG C) thick paste, by above-mentioned thick paste with
Cornstarch is dry at 60 DEG C after mixing evenly, and the amount of cornstarch is the 30% of thick paste quality, when being dried to moisture≤5%,
The dry extract dried is broken into fine powder, obtains Foliole banyan dry extract powder；Micro mist silicon is added into above-mentioned Foliole banyan dry extract powder
Glue, the weight of superfine silica gel powder are the 1/95 of above-mentioned Foliole banyan dry extract powder weight, first stir 10min with the speed of 300r/min,
Again with the speed of 1200r/min stirring 6min to get.
The preparation method of ketelin capsule:
S1 takes the chlorphenamine maleate of formula ratio and Foliole banyan dry extract powder to be put into bag film inner sealing sack, Ficus microcarpa
The weight of dry extract is identical as the weight of above-mentioned chlorphenamine maleate, and shaking mixes, and 40 meshes excessively are primary, obtains mixed powder A；
S2 stirs evenly mixed powder A obtained by step S1 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
2 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder B；
S3 stirs evenly mixed powder B obtained by step S2 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
4 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder C；
S4 stirs evenly mixed powder C obtained by step S3 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
8 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain chlorphenamine maleate premixed powder；
S5 is by horse obtained by the Foliole banyan dry extract powder of surplus, talcum powder, magnesium stearate, multifunction additive and step S4
Carry out sour chlorphenamine premixed powder and be added to the mixer mixing, mixing speed 2000r/min, mixing time 8min obtains cough
Trane capsule mixed powder；
Ketelin capsule mixed powder obtained by step S5 is packed into capsule shells by S6, sterilizing to get.
Ketelin capsule described in embodiment 2, a kind of ketelin capsule is made of ketelin capsule mixed powder and capsule shells, institute
Stating ketelin capsule mixed powder includes following components and its parts by weight:
370 parts of Foliole banyan dry extract powder, 1.5 parts of chlorphenamine maleate, 17 parts of talcum powder, 7 parts of magnesium stearate, average mark
Son amount is 4 parts of polyvinylpyrrolidone, 2 parts of multifunction additive of 24000；The multifunction additive is by carboxymethyl chitosan
Sugar, tartaric acid and microcrystalline cellulose are formed by weight 4:9:20；The Foliole banyan dry extract powder is Foliole banyan dry extract powder
Modifier.
The modifier of the Foliole banyan dry extract powder the preparation method comprises the following steps: take Ficus microcarpa dried leaf, add water to cook twice, water
Additive amount be 6 times of above-mentioned Ficus microcarpa dried leaf weight, decoct 1.5h for the first time, decoct 1h for second, collecting decoction,
The filtration of 120 meshes, filtrate are concentrated into the clear cream that relative density is 1.20 (80 DEG C), let cool, and ethyl alcohol is added and reaches alcohol content
60%, stand for 24 hours, filtration, filtrate recycling ethanol, be concentrated into relative density be 1.30 (50 DEG C) thick paste, by above-mentioned thick paste with
Cornstarch is dry at 75 DEG C after mixing evenly, and the amount of cornstarch is the 35% of thick paste quality, when being dried to moisture≤5%,
The dry extract dried is broken into fine powder, obtains Foliole banyan dry extract powder；Micro mist silicon is added into above-mentioned Foliole banyan dry extract powder
Glue, the weight of superfine silica gel powder are the 1/95 of above-mentioned Foliole banyan dry extract powder weight, first stir 15min with the speed of 500r/min,
Again with the speed of 1500r/min stirring 10min to get.
The preparation method of ketelin capsule:
S1 takes the chlorphenamine maleate of formula ratio and Foliole banyan dry extract powder to be put into bag film inner sealing sack, Ficus microcarpa
The weight of dry extract is identical as the weight of above-mentioned chlorphenamine maleate, and shaking mixes, and 40 meshes excessively are primary, obtains mixed powder A；
S2 stirs evenly mixed powder A obtained by step S1 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
2 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder B；
S3 stirs evenly mixed powder B obtained by step S2 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
4 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder C；
S4 stirs evenly mixed powder C obtained by step S3 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
8 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain chlorphenamine maleate premixed powder；
S5 is by horse obtained by the Foliole banyan dry extract powder of surplus, talcum powder, magnesium stearate, multifunction additive and step S4
Carry out sour chlorphenamine premixed powder and be added to the mixer mixing, mixing speed 3000r/min, mixing time 15min obtains cough
Trane capsule mixed powder；
Ketelin capsule mixed powder obtained by step S5 is packed into capsule shells by S6, sterilizing to get.
Ketelin capsule described in embodiment 3, a kind of ketelin capsule is made of ketelin capsule mixed powder and capsule shells, institute
Stating ketelin capsule mixed powder includes following components and its parts by weight:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, average mark
Son amount is 3 parts of polyvinylpyrrolidone, 1.5 parts of multifunction additive of 10000；The multifunction additive is by carboxymethyl chitosan
Sugar, tartaric acid and microcrystalline cellulose are formed by weight 3:10:23；The Foliole banyan dry extract powder is Foliole banyan dry extract powder
Modifier.
The modifier of the Foliole banyan dry extract powder the preparation method comprises the following steps: take Ficus microcarpa dried leaf, add water to cook twice, water
Additive amount be 5 times of above-mentioned Ficus microcarpa dried leaf weight, decoct 1.5h for the first time, decoct 1h for second, collecting decoction,
The filtration of 120 meshes, filtrate are concentrated into the clear cream that relative density is 1.15 (80 DEG C), let cool, and ethyl alcohol is added and reaches alcohol content
60%, stand 16h, filtration, filtrate recycling ethanol, be concentrated into relative density be 1.30 (50 DEG C) thick paste, by above-mentioned thick paste with
Cornstarch is dry at 70 DEG C after mixing evenly, and the amount of cornstarch is the 33% of thick paste quality, when being dried to moisture≤5%,
The dry extract dried is broken into fine powder, obtains Foliole banyan dry extract powder；Micro mist silicon is added into above-mentioned Foliole banyan dry extract powder
Glue, the weight of superfine silica gel powder are the 1/95 of above-mentioned Foliole banyan dry extract powder weight, first stir 12min with the speed of 400r/min,
Again with the speed of 1300r/min stirring 8min to get.
The preparation method of ketelin capsule:
S1 takes the chlorphenamine maleate of formula ratio and Foliole banyan dry extract powder to be put into bag film inner sealing sack, Ficus microcarpa
The weight of dry extract is identical as the weight of above-mentioned chlorphenamine maleate, and shaking mixes, and 40 meshes excessively are primary, obtains mixed powder A；
S2 stirs evenly mixed powder A obtained by step S1 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
2 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder B；
S3 stirs evenly mixed powder B obtained by step S2 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
4 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain mixed powder C；
S4 stirs evenly mixed powder C obtained by step S3 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is
8 times of chlorphenamine maleate weight in step S1,40 meshes excessively are primary, obtain chlorphenamine maleate premixed powder；
S5 is by horse obtained by the Foliole banyan dry extract powder of surplus, talcum powder, magnesium stearate, multifunction additive and step S4
Carry out sour chlorphenamine premixed powder and be added to the mixer mixing, mixing speed 2500r/min, mixing time 10min obtains cough
Trane capsule mixed powder；
Ketelin capsule mixed powder obtained by step S5 is packed into capsule shells by S6, sterilizing to get.
Comparative example 1, a kind of ketelin capsule
The ketelin capsule is made of ketelin capsule mixed powder and capsule shells, and the ketelin capsule mixed powder includes
Following components and its parts by weight:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, average mark
Son amount is 3 parts of polyvinylpyrrolidone, 1.5 parts of multifunction additive of 30000；The multifunction additive is by carboxymethyl chitosan
Sugar, tartaric acid and microcrystalline cellulose are formed by weight 3:10:23；The Foliole banyan dry extract powder is Foliole banyan dry extract powder
Modifier.
The modifier of the Foliole banyan dry extract powder, the preparation method of ketelin capsule are similar to Example 3.
Difference with embodiment 3 is that the average molecular weight of polyvinylpyrrolidone is 30000.
Comparative example 2, a kind of ketelin capsule
The ketelin capsule is made of ketelin capsule mixed powder and capsule shells, and the ketelin capsule mixed powder includes
Following components and its parts by weight:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, average mark
Son amount is 3 parts of polyvinylpyrrolidone, 1.5 parts of multifunction additive of 10000；The multifunction additive is by carboxymethyl chitosan
Sugar, tartaric acid and microcrystalline cellulose are formed by weight 1:1:1；The Foliole banyan dry extract powder is changing for Foliole banyan dry extract powder
Property object.
The modifier of the Foliole banyan dry extract powder, the preparation method of ketelin capsule are similar to Example 3.
Difference with embodiment 3 is that the multifunction additive is by carboxymethyl chitosan, tartaric acid and microcrystalline cellulose
It is formed by weight 1:1:1.
Comparative example 3, a kind of ketelin capsule
The ketelin capsule is made of ketelin capsule mixed powder and capsule shells, and the ketelin capsule mixed powder includes
Following components and its parts by weight:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, average mark
Son amount is 3 parts of polyvinylpyrrolidone, 1.5 parts of multifunction additive of 10000；The multifunction additive is by tartaric acid and micro-
Crystalline cellulose is formed by weight 10:23；The Foliole banyan dry extract powder is the modifier of Foliole banyan dry extract powder.
The modifier of the Foliole banyan dry extract powder, the preparation method of ketelin capsule are similar to Example 3.
Difference with embodiment 3 is that the multifunction additive is by tartaric acid and microcrystalline cellulose by weight 10:23
Composition.
Comparative example 4, a kind of ketelin capsule
The ketelin capsule is made of ketelin capsule mixed powder and capsule shells, and the ketelin capsule mixed powder includes
Following components and its parts by weight:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, average mark
Son amount is 3 parts of polyvinylpyrrolidone, 1.5 parts of multifunction additive of 10000；The multifunction additive is by carboxymethyl chitosan
Sugar, tartaric acid and microcrystalline cellulose are formed by weight 3:10:23.
The Foliole banyan dry extract powder the preparation method comprises the following steps: take Ficus microcarpa dried leaf, add water to cook twice, the additive amount of water
It is 5 times of above-mentioned Ficus microcarpa dried leaf weight, decocts 1.5h, second of decoction 1h, collecting decoction, the filter of 120 meshes for the first time
It crosses, filtrate is concentrated into the clear cream that relative density is 1.15 (80 DEG C), lets cool, and ethyl alcohol is added and makes alcohol content up to 60%, stands
16h, filtration, filtrate recycling ethanol are concentrated into the thick paste that relative density is 1.30 (50 DEG C), above-mentioned thick paste are stirred with cornstarch
Dry at 70 DEG C after mixing uniformly, the amount of cornstarch is the 33% of thick paste quality, when being dried to moisture≤5%, by what is dried
Dry extract is broken into fine powder, obtains Foliole banyan dry extract powder.
The preparation method of the ketelin capsule is similar to Example 3.
Difference with embodiment 3 is that the Foliole banyan dry extract powder is modified.
The long-term stable experiment of test example one, ketelin capsule
1, test specimen: embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and comparative example 4 are made
Standby ketelin capsule.
2, test method:
By test specimen in incubator (25 DEG C, relative humidity 60%), store 36 months, respectively at 0,3,6,9,12,
18, it is detected within 24,36 months.Detect its character, identification, disintegration time limited, moisture, content, microbial limit.
3, test result: the results are shown in Table 1 for the long-term stable experiment of ketelin capsule.
Table 1: the long-term stable experiment result of ketelin capsule
As shown in Table 1, ketelin capsule made from embodiment 1-3 is at 25 DEG C, relative humidity 60%, after storage 36 months,
Character, identification, disintegration time limited, moisture etc. meet the requirements, and illustrate that the stability of ketelin capsule produced by the present invention is high, guarantee the quality
Phase is long；Compared with comparative example 1-4, the stability of ketelin capsule made from the embodiment of the present invention 3 is higher, illustrates that cough of the present invention is special
Curing capsule is unlikely to deteriorate in long-term place, property is stablized.
Test example two, mobility and content uniformity test
1.1, fluidity test:
Example 1-3 and comparative example 1,4 step S5 gained ketelin capsule mixed powder of comparative example, using fixed cone method
Measure angle of repose.Angle of repose is the method for examining powder fluidity quality, and angle of repose is smaller, and frictional force is smaller, and mobility is better,
It can satisfy the needs of production mobility when the angle of repose of general powder is less than 40 °.
1.2, content uniformity is tested
According to content uniformity detection method in " Chinese Pharmacopoeia " 2015 editions 10 capsules of third portion general rule to embodiment 1-3 and
Ketelin capsule made from comparative example 1, comparative example 4 carries out content uniformity detection.
2, test result: mobility and content uniformity measurement result are shown in Table 2.
Table 2: mobility and content uniformity measurement result
| Project | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 4 |
| Angle of repose | 22.8° | 23.5° | 22.4° | 33.5° | 36.8° |
| Content uniformity limit | ± 4.6% | ± 5.2% | ± 4.2% | ± 6.8% | ± 8.0% |
As shown in Table 2, the content uniformity of ketelin capsule produced by the present invention meets regulation, and Ketelin glue in its preparation
The mobility of capsule mixed powder is preferable, and wherein the mobility of embodiment 3 is best, and content uniformity is minimum, is best implementation of the invention
Example.Compared with comparative example 1,4, the mobility of ketelin capsule mixed powder of the present invention is more excellent, and content uniformity is smaller.
The cloud test of chlorphenamine maleate in test example three, ketelin capsule
1, test specimen: ketelin capsule prepared by embodiment 1, embodiment 2, embodiment 3, comparative example 2, comparative example 3.
2, test method: according to " Chinese Pharmacopoeia " 2015 version two, Content uniformity test operation.
3, test result: the uniformity test result of chlorphenamine maleate is as shown in table 3 in ketelin capsule.
Table 3: the uniformity test result of chlorphenamine maleate in ketelin capsule
| Project | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 2 | Comparative example 3 |
| A+1.8S | 6.4 | 6.6 | 6.2 | 9.5 | 11.2 |
As shown in Table 3, the A+1.8S of ketelin capsule produced by the present invention is respectively 6.4,6.6,6.2, respectively less than 15.0,
Illustrate that uniformity of dosage units meets regulation, wherein the A+1.8S of ketelin capsule made from embodiment 3 is minimum, for it is of the invention most
Good embodiment；Compared with comparative example 2,3, the A+1.8S of ketelin capsule of the present invention is smaller, illustrates in ketelin capsule of the present invention
The uniformity of chlorphenamine maleate is higher.
Test example four, ketelin capsule are to respiratory system cough, phlegm, the effect for breathing heavily animal pattern
1, test material: ketelin capsule made from embodiment 3 and comparative example 2, comparative example 3.
2, subjects: Kunming mouse 100, weight 20g, half male and half female；Cavy 40, weight 250g, male and female are each
Half.
3, test method:
3.1, antitussive effect of the ketelin capsule to mouse
50 mouse are taken, blank control group, positive drug control group, 3 groups of embodiment, 2 groups of comparative example, comparison are randomly divided into
3 groups of example, every group 10, half male and half female.Blank control group is oral give 1.0mL/ day ordinary water, positive drug control group gives cough
2 groups of flat 0.05g/kg, 3 groups of embodiment and comparative example, 3 groups of comparative example give embodiment 3 and comparative example 2 respectively, comparative example 3 is made
The each 0.05g/kg weight gastric infusion of ketelin capsule be administered twice altogether once a day, 1h after the last administration, in order
It is to throw the cotton balls that 0.2mL aqua ammonia is added dropwise in 300mL wide-mouth bottle (bottleneck coats vaseline) that mouse, which is placed in volume, respectively
Enter in bottle, starts to observe and record mouse and the time (cough latent period) of Respiratory frequency occur.Test result is as shown in table 4.
3.2, phlegm-dispelling functions of the ketelin capsule to cavy
50 mouse are taken, blank control group, positive drug control group, 3 groups of embodiment, 2 groups of comparative example, comparison are randomly divided into
3 groups of example, every group 10, half male and half female.Blank control group is oral give 1.0mL/ day ordinary water, positive drug control group gives chlorine
Change ammonium 1.25g/kg, 2 groups of 3 groups of embodiment and comparative example, 3 groups of comparative example give embodiment 3 respectively and comparative example 2, comparative example 3 are made
The each 1.25g/kg weight gastric infusion of ketelin capsule obtained is administered twice altogether once a day, after the last administration 30min, respectively
0.25% phenol red solution 0.2mL/ is injected intraperitoneally only in group mouse, and the vertebra that breaks after 30min puts to death animal, separates tracheae, uses syringe
5% sodium bicarbonate solution is quantitatively drawn, tracheae is rinsed with certain number and speed, concentrates flushing liquor, centrifugation takes supernatant 730
Colorimetric at type ultraviolet specrophotometer 510nm.Test result is as shown in table 5.
3.3, effect of the ketelin capsule to guinea pig experimental asthma
40 cavys are taken, are randomly divided into blank control group, 3 groups of embodiment, 2 groups of comparative example, 3 groups of comparative example, every group 10,
Half male and half female.Blank control group is oral give 1.0mL/ day ordinary water, 3 groups of embodiment, 2 groups of comparative example, 3 groups of comparative example give respectively
It is every to give each 100g/kg weight gastric infusion of ketelin capsule, every cavy made from embodiment 3 and comparative example 2, comparative example 3
Day oral administration is primary, and successive administration seven days, cavy, was placed in reaction chamber by 1h respectively in order after the last administration, with 4% group
Amine (national standard) solution is sprayed 20S (spraying 10mL, occur overturning as indicator reaction with cavy) under a constant, starts
It observes and records cavy and the time overturned occurs, calculate the stoichiometric number in 2min, calculated more than 2min person by 2min.Test result
As shown in table 6.
Table 4: antitussive effect of the ketelin capsule to mouse
| Group | Number of mice (only) | Cough latent period (S) |
| Blank control group | 10 | 36.15 |
| Positive drug control group | 10 | 70.24 |
| 3 groups of embodiment | 10 | 82.45 |
| 2 groups of comparative example | 10 | 58.37 |
| 3 groups of comparative example | 10 | 48.32 |
As shown in Table 4, compared with blank control group, ketelin capsule produced by the present invention, which draws cough mouse to ammonium hydroxide, to be had
Apparent antitussive effect, and difference has conspicuousness, and its antibechic effect is more preferable compared with positive drug control group；With comparative example 2,
3 groups are compared, and the antibechic effect of ketelin capsule produced by the present invention is more superior.
Table 5: phlegm-dispelling functions of the ketelin capsule to mouse
| Group | Number of mice (only) | Light transmittance (T%) |
| Blank control group | 10 | 90.38 |
| Positive drug control group | 10 | 78.65 |
| 3 groups of embodiment | 10 | 72.48 |
| 2 groups of comparative example | 10 | 83.22 |
| 3 groups of comparative example | 10 | 86.13 |
As shown in Table 5, compared with blank control group, ketelin capsule produced by the present invention can obviously increase Respiratory Tract of Mice
The phenol red amount of mucous membrane discharge, illustrates it with apparent phlegm-dispelling functions, and its expectorant effect is more preferable compared with positive drug control group；
Compared with 2,3 groups of comparative example, the expectorant effect of ketelin capsule produced by the present invention is more preferably.
Table 6: effect of the ketelin capsule to guinea pig experimental asthma
| Group | Cavy number (only) | It reacts time of occurrence (S) |
| Blank control group | 10 | 73.34 |
| 3 groups of embodiment | 10 | 128.36 |
| 2 groups of comparative example | 10 | 105.42 |
| 3 groups of comparative example | 10 | 93.15 |
As shown in Table 6, compared with blank control group, ketelin capsule produced by the present invention can it is obvious after prolong Experimental Asthma In Guinea-pigs hair
Make the time, there is antiasthmatic effect；Compared with 2,3 groups of comparative example, the antiasthmatic effect of ketelin capsule produced by the present invention is more aobvious
It writes.
Claims (9)
1. a kind of ketelin capsule, which is characterized in that be made of ketelin capsule mixed powder and capsule shells, the ketelin capsule
Mixed powder includes following components and its parts by weight:
350-370 parts of Foliole banyan dry extract powder, 1.2-1.5 parts of chlorphenamine maleate, 10-17 parts of talcum powder, magnesium stearate 5-7
Part, 2-4 parts of polyvinylpyrrolidone, 1-2 parts of multifunction additive.
2. ketelin capsule as described in claim 1, which is characterized in that the ketelin capsule mixed powder by following components and
Its parts by weight composition:
360 parts of Foliole banyan dry extract powder, 1.4 parts of chlorphenamine maleate, 15 parts of talcum powder, 6 parts of magnesium stearate, polyvinyl pyrrole
3 parts of alkanone, 1.5 parts of multifunction additive.
3. ketelin capsule as claimed in claim 1 or 2, which is characterized in that the mean molecule of the polyvinylpyrrolidone
Amount is 8000-24000.
4. ketelin capsule as claimed in claim 3, which is characterized in that the average molecular weight of the polyvinylpyrrolidone is
10000。
5. ketelin capsule as claimed in claim 1 or 2, which is characterized in that the multifunction additive is by carboxymethyl chitosan
Sugar, tartaric acid and microcrystalline cellulose are formed by weight 2-4:9-12:20-25.
6. ketelin capsule as claimed in claim 5, which is characterized in that the multifunction additive by carboxymethyl chitosan,
Tartaric acid and microcrystalline cellulose are formed by weight 3:10:23.
7. ketelin capsule as claimed in claim 1 or 2, which is characterized in that the Foliole banyan dry extract powder is dry for Ficus microcarpa
The modifier of extract powder.
8. ketelin capsule as claimed in claim 7, which is characterized in that the preparation of the modifier of the Foliole banyan dry extract powder
Method are as follows: take Foliole banyan dry extract powder, superfine silica gel powder is added, the weight of superfine silica gel powder is above-mentioned Foliole banyan dry extract powder weight
1/95,10-15min is first stirred with the speed of 300-500r/min, then 6-10min is stirred with the speed of 1200-1500r/min,
To obtain the final product.
9. such as the preparation method of the described in any item ketelin capsules of claim 1-8, which comprises the following steps:
S1 takes the chlorphenamine maleate of formula ratio and Foliole banyan dry extract powder is put into bag film inner sealing sack, the dry leaching of Ficus microcarpa
The weight of cream powder is identical as the weight of above-mentioned chlorphenamine maleate, and shaking mixes, and 40 meshes excessively are primary, obtains mixed powder A；
S2 stirs evenly mixed powder A obtained by step S1 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is step
2 times of chlorphenamine maleate weight in S1,40 meshes excessively are primary, obtain mixed powder B；
S3 stirs evenly mixed powder B obtained by step S2 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is step
4 times of chlorphenamine maleate weight in S1,40 meshes excessively are primary, obtain mixed powder C；
S4 stirs evenly mixed powder C obtained by step S3 with Foliole banyan dry extract powder, and the weight of Foliole banyan dry extract powder is step
8 times of chlorphenamine maleate weight in S1,40 meshes excessively are primary, obtain chlorphenamine maleate premixed powder；
S5 is by maleic acid obtained by the Foliole banyan dry extract powder of surplus, talcum powder, magnesium stearate, multifunction additive and step S4
Chlorphenamine premixed powder is added to the mixer mixing, mixing speed 2000-3000r/min, mixing time 8-15min,
Obtain ketelin capsule mixed powder；
Ketelin capsule mixed powder obtained by step S5 is packed into capsule shells by S6, sterilizing to get.
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Non-Patent Citations (1)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典2015年版一部》", 30 June 2015, 中国医药科技出版社 * |
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Address after: 526200 Fengshan Road, Dongcheng District, Sihui City, Guangdong, Zhaoqing Applicant after: Yili Pharmaceutical Co.,Ltd. Address before: 526200 Fengshan Road, Dongcheng District, Sihui City, Guangdong, Zhaoqing Applicant before: GUANGDONG YILI GROUP PHARMACEUTICAL Co.,Ltd. |
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